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Terminated

Synthes Trauma Ex-Fix System (Small, Medium, Distraction Osteogenesis (DO) and Large) ; (S) intended to stabilize and provide treatment for fractures of the small bones, such as the hand, wrist, forearm, foot, and ankle; (M) for the construction of an external fixation frame for the treatment of pediatric and adult fractures; )L) for use to provide treatment for long bone and pelvic fractures that require external fixation; and (DO) for fracture fixation (open and closed),pseudoarthrosis or non-unions of long bones, limb lengthening by epiphyseal or metaphysical distraction, correction of bony or soft tissue deformities and correction of segmental bony or soft tissue defects in adult and pediatric patients.

FDA Recall Z-2451-2015 · Posted 2015-08-24

Recalling FirmSynthes (USA) Products LLC
Recall StatusTerminated
Product CodeKTT
Date Initiated2015-07-29
Date Terminated2016-09-27
Product Quantity5306080

Reason for Recall

Labeling changes were made related to MR conditions that align with standard definitions for MR Safe, MR Conditional, and MR Unsafe. This recall identifies additional Trauma External Fixation System part numbers that should be considered MR Conditional. One serious injury reported.

Firm Action

Urgent recall letters, dated July 31, 2015, were sent to end users and sales consultants to notifiy them about the issue, the associated risks, and to provide instructions for returning the affected devices and response form.

Root Cause

Labeling design

Distribution Pattern

Worldwide Distribution-including US (nationwide) and Canada.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K122455SYNTHES SMALL EXTERNAL FIXATION SYSTEM, SYNTHES LARGE EXTERNAL FIXATION SYSTEMSynthes · 2013-04-11K082650SYNTHES LARGE EXTERNAL FIXATION, MR CONDITIONALSynthes (Usa) · 2008-11-18K033158SYNTHES REPROCESSED EXTERNAL FIXATION DEVICESSynthes (Usa) · 2003-11-05K031428SYNTHES (USA) LARGE EXTERNAL FIXATION CLAMPS-MR SAFESynthes (Usa) · 2003-08-08K030390SYNTHES LARGE COMBINATION CLAMP AND DYNAMIZATION CLIP - MR SAFESynthes (Usa) · 2003-04-01

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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